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Human Health Hazard Threshold Values


Table 2B Threshold Values for Human Health Chemical Hazard Endpoints

DRAFT- NOT FINAL (Dec, 2009)

Hazard

 

Very High (H)

 

High (H)

 

Moderate (M)

 

Low (L)

 

Carcinogenicity*

 

Recommended Test Methods and Models

 

 

· GHS Category 1A or 1B

· Authoritative and/or Screening Lists

· GHS Category 2

· Authoritative and/or Screening Lists

· Meets DfE General Screen Criteria for Carcinogenicity

 

· Authoritative and/or Screening Lists

 

Mutagenicity/Genotoxicity*

 

Recommended Test Methods and Models

 

 

· GHS Category 1A or 1B

· Authoritative and/or Screening Lists

· GHS Category 2

· Authoritative and/or Screening Lists

· Meets DfE General Screen Criteria for Genetic Toxicity

 

Reproductive/Developmental toxicity*

 

Recommended Test Methods and Models

 

 

· GHS Category 1A or 1B

· Authoritative and/or Screening Lists

· GHS Category 2 or Effects on Lactation

· Authoritative and/or Screening Lists

· Meets DfE General Screen Criteria for Reproductive and Developmental Toxicity

 

Endocrine Disruption*

 

Recommended Test Methods and Models for Endocrine Mediated Effect (e.g. carcinogenicity, reproductive/developmental toxicity, repeated dose toxicity)

 

 

· Weight of evidence demonstrates possible endocrine system mediated effects and high potency

· Screening List

· Weight of evidence demonstrates possible endocrine system mediated effect that are lower potency and/or reversible effects

· Screening List

· Meets DfE General Screen for each endpoint related to an endocrine system mediated effect (e.g. carcinogenicity, reproductive/developmental toxicity, repeated dose toxicity)

 

· Screening List

 

 

 

Neurotoxicity*

Recommended Test Methods and Models

 

· Weight of evidence demonstrates potential for irreversible neurotoxic effects in humans or developmental neurotoxicity in humans

· Screening List

· Weight of evidence demonstrates potential for neurotoxic effects in humans

· Screening List

· Meets DfE General Screen for Neurotoxicity

 

 

 

 

 

Acute Mammalian Toxicity (oral, dermal and inhalation)

Recommended Test Methods and Models

 

· GHS Category 1 or 2

Authoritative and/or Screening Lists

· GHS Category 3

· Authoritative and/or Screening Lists

· GHS Category 4

· Authoritative and/or Screening Lists

· Meets DfE General Screen for Acute Mammalian Toxicity

 

 

 

Corrosion/Irritation of the Skin or Eye

Recommended Test Methods and Models

 

 

· GHS Category 1 Skin

· GHS Category 1 Eye

· Authoritative and/or Screening Lists

· GHS Category 2 Skin

· GHS Category 2A Eye

· Authoritative and/or Screening Lists

· GHS Category 3 Skin

· GHS Category 2B Eye

· GHS not classifiable

· Authoritative and/or Screening Lists

Sensitization of the Skin or Respiratory System

 

Recommended Test Methods and Models for Skin Sensitization, Respiratory Sensitization

 

 

· GHS Category 1 Respiratory Sensitizer

·  GHS Category 1A Skin Sensitizer

· Authoritative and/or Screening Lists

 

· GHS Category 1B Skin Sensitizer

· Authoritative and/or Screening Lists

· Meets DfE General Screen for Respiratory Sensitization and Skin Sensitization

 

Systemic Toxicity/Organ Effects (via single or repeated exposure, includes immunotoxicity)

Recommended Test Methods and Models for Single Exposure, Repeated Exposure, Immunotoxicity

 

· GHS Category 1 single exposure

· Authoritative and/or Screening Lists

· GHS Category 2 single exposure

· GHS Category 1 repeated exposure

· Authoritative and/or Screening Lists

· GHS Category 3 single exposure

· GHS Category 2 repeated exposure

· Authoritative and/or Screening Lists

· Meets DfE General Screen for Repeated Dose Toxicity. Must include evaluation of immune system effects.

· Not classifiable for GHS organ toxicity single exposure or repeated exposure.

 

 

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